Vascular device and method for valve leaflet apposition

ABSTRACT

A vascular device having a plurality of struts having a distal portion and a proximal portion. The distal portion of the struts are retained in a converged position. The struts diverge radially outwardly. A plurality of vessel penetrating members extend from the proximal portion of the struts for engaging the internal wall of the vessel, wherein release of the retention of the distal portions of the struts causes the distal portions to move outwardly away from the longitudinal axis and the proximal portions of the struts to move inwardly toward the longitudinal axis such that the vessel engaging members pull the internal wall of the vessel radially inwardly.

This application claims priority from provisional application Ser. No.61/638,643, filed Apr. 26, 2012, the entire contents of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a vascular device and more particularly to avascular device for approximating vein valve leaflets for treatingvenous valve insufficiency.

2. Background of Related Art

Veins in the body transport blood to the heart and arteries carry bloodaway from the heart. The veins have one-way valve structures in the formof leaflets disposed annularly along the inside wall of the vein whichopen to permit blood flow toward the heart and close to prevent backflow. That is, when blood flows through the vein, the pressure forcesthe valve leaflets apart as they flex in the direction of blood flow andmove towards the inside wall of the vessel, creating an openingtherebetween for blood flow. The leaflets, however, do not normally bendin the opposite direction and therefore return to a closed position toprevent blood flow in the opposite, i.e. retrograde, direction after thepressure is relieved. The leaflet structures, when functioning properly,extend radially inwardly toward one another such that the tips contacteach other to block backflow of blood.

In the condition of venous valve insufficiency, the valve leaflets donot function properly as they thicken and lose flexibility, resulting intheir inability to extend sufficiently radially inwardly to enable theirtips to come into sufficient contact with each other to preventretrograde blood flow. The retrograde blood flow causes the buildup ofhydrostatic pressure on the residual valves and the weight of the blooddilates the wall of the vessel. Such retrograde blood flow, commonlyreferred to as reflux, leads to swelling and varicose veins, causinggreat discomfort and pain to the patient. Such retrograde blood flow, ifleft untreated can also cause venous stasis ulcers of the skin andsubcutaneous tissue. There are generally two types of venous valveinsufficiency: primary and secondary. Primary venous valve insufficiencyis typically a condition from birth, where the vein is simply too largein relation to the leaflets so that the leaflets cannot come intoadequate contact to prevent backflow. More common is secondary venousvalve insufficiency which is caused by clots which gel and scar, therebychanging the configuration of the leaflets, i.e., thickening theleaflets creating a “stub-like” configuration. Venous valveinsufficiency can occur in the superficial venous system, such as thesaphenous veins in the leg, or in the deep venous system, such as thefemoral and popliteal veins extending along the back of the knee to thegroin.

A common method of treatment of venous valve insufficiency is placementof an elastic stocking around the patient's leg to apply externalpressure to the vein, forcing the walls radially inwardly to force theleaflets into apposition. Although sometimes successful, the tightstocking is quite uncomfortable, especially in warm weather, as thestocking must be constantly worn to keep the leaflets in apposition. Theelastic stocking also affects the patient's physical appearance, therebypotentially having an adverse psychological affect. This physical and/orpsychological discomfort sometimes results in the patient removing thestocking, thereby preventing adequate treatment.

Another method of treatment has been developed to avoid the discomfortof the stocking. This method involves major surgery requiring theimplantation of a cuff internally of the body, directly around the vein.This surgery requires a large incision, resulting in a long patientrecovery time, scarring and carries the risks, e.g. anesthesia, inherentwith surgery.

Another invasive method of surgery involves selective repairing of thevalve leaflets, referred to as valvuloplasty. In one method, sutures areutilized to bring the free edges of the valve cusp into contact. Thisprocedure is complicated and has the same disadvantages of the majorsurgery described above.

It would therefore be advantageous to provide a method and device tominimally invasively treat venous valve insufficiency without requiringan outer stocking or internal cuff. Such device would thereby avoid thephysical and psychological discomfort of an external stocking as well asavoid the risk, complexity and expense of surgically implanted cuffs.Such device would advantageously be inserted minimally invasively, i.e.,intravascularly, and function to effectively bring the valve leafletsinto apposition.

Commonly assigned U.S. Pat. Nos. 6,695,878 and 6,527,800, the entirecontents of which are incorporated herein by reference, disclose anadvantageous method and device to minimally invasively treat venousvalve insufficiency without requiring an outer stocking or internalcuff. Such device avoids the physical and psychological discomfort of anexternal stocking as well as avoids the risk, complexity and expense ofsurgically implanted cuffs. The device is advantageously insertedminimally invasively, i.e., intravascularly, and functions toeffectively bring the valve leaflets into apposition. This device firstexpands against the vessel wall to grasp the wall, and then contracts tobring the vessel wall radially inwardly so the leaflets can be pulledcloser together to a functional position.

The vascular devices of commonly assigned U.S. Pat. No. 6,676,698 andPatent Publication No. 2009/0062901, the entire contents of which areincorporated by reference herein, utilizes the device of these foregoingapplications for bringing the vessel wall radially inwardly to correctthe dilation of the wall, but rather than rely on the patient's existingvalve leaflets which may be scarred or non-functional, contain areplacement valve as a substitute for the patient's leaflets. Thus,advantageously, venous valve insufficiency can be treated minimallyinvasively by bringing the vessel wall inwardly and replacing thepatient's valve.

It would be beneficial to further minimize the dimension of a minimallyinvasive vascular device for approximating valve leaflets to facilitateinsertion of the device, and would also be beneficial to reduce thecomplexity of the device.

SUMMARY

The present disclosure provides an intravascular device which brings thevessel wall adjacent the vein valve radially inwardly to bring valveleaflets into apposition. In one aspect, a vascular device is providedcomprising a longitudinal axis and a plurality of struts having a distalportion and a proximal portion. The distal portion of the struts areretained in a converged position, the struts diverging radiallyoutwardly proximally in the converged position. A plurality of vesselengaging members extend from the proximal portion of the struts forengaging the internal wall of the vessel, wherein release of retentionof the distal portions of the struts causes the distal portions of thestruts to move outwardly away from the longitudinal axis and theproximal portions of the struts to move inwardly toward the longitudinalaxis such that the vessel engaging members pull the internal wall of thevessel radially inwardly.

In some embodiments, the device is composed of shape memory material andrelease of the retention member enables the struts to return to theirshape memorized position.

In some embodiments, the device is substantially conical when the distalportions of the struts are retained in the converged position.

In some embodiments, the device includes a retention member which ismoved in a distal direction to release the distal portions of thestruts.

The device can have connecting struts in an intermediate region of thestruts.

In some embodiments, the device is substantially oval in transversecross-section to form a shorter dimension and a longer dimension, withthe longer dimension preferably substantially in line with the valvecommissure.

The vessel engaging members can have sharp ends angled outwardly anddistally. The device in some embodiments is formed from a tube and thestruts are formed from cutouts in the tube.

In accordance with another aspect of the present disclosure, a vasculardevice is provided comprising a tubular-like member having proximal,intermediate and distal portions, the tubular like member beingexpandable from a collapsed configuration to an expanded configuration.A plurality of vessel engaging members with penetrating tips extend fromthe proximal portion, wherein expansion of the member to the expandedconfiguration causes the proximal portions to move outwardly topenetrate the vessel wall, and subsequent release of the distal portionsmoves the vessel engaging members radially inwardly to move the vesselwall inwardly.

In some embodiments, the tubular-like member includes a plurality oflongitudinal struts and connecting struts interconnecting adjacentlongitudinal struts. The device preferably includes a retention memberretaining the distal portions of the tubular like member in a convergedposition, the retention member releasable to release the distal portionsto enable movement of the distal portions radially outwardly to a spreadposition. In some embodiments, the device is substantially oval incross-sectional dimension.

In accordance with another aspect of the present disclosure, a methodfor treating venous valve insufficiency is provided comprising the stepsof:

-   -   inserting a delivery device and a vascular device having a        plurality of legs into a target vessel adjacent valve leaflets        of the vessel;    -   deploying the vascular device from the delivery device to move a        proximal portion of the legs radially outwardly to engage the        vessel wall; and    -   releasing the distal portion of the legs to enable the proximal        portion of the legs to move radially inwardly to move the vessel        wall radially inwardly and bring the valve leaflets closer        together.

The method can further include the step of moving a retention member ofthe vascular device axially to release a distal portion of the legs. Insome embodiments, the step of releasing the distal portion of the legsenables the vascular device to return to a shape memorized position. Themethod can further include the step of pulling the retention memberproximally to move the legs proximally into contact with the deliverydevice so that the delivery device cams the legs further outwardly.

Preferably, in the expanded deployed position, the vessel engagingportions of the vascular device are closer to a center longitudinal axisof the device than the distal portions of the device.

In some embodiments, the step of deploying the vascular device to deployit to an enlarged diameter moves a plurality of penetrating tips ofvessel engaging members extending from the proximal portions of thevascular device to penetrate the internal wall of the vessel.

In some embodiments, the delivery device is inserted to a positionupstream of the valve leaflets to deliver the vascular device upstreamof the valve leaflets; in other embodiments, the delivery device isinserted to a position downstream of the valve leaflets to deliver thevascular device downstream of the valve leaflets.

In some embodiments, the delivery device is inserted through the jugularvein into the popliteal vein or the saphenous vein.

In some embodiments, the vascular device is inserted through thesaphenous vein or the popliteal vein to a position downstream of thevalve leaflets; in other embodiments, the vascular device is insertedthrough the saphenous vein or the popliteal vein to a position upstreamof the valve leaflets.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of the vascular device of the presentdisclosure shown in the fully deployed configuration;

FIG. 2 is a side view of the vascular device of FIG. 1 in the collapsedconfiguration being delivered into the vessel;

FIG. 3 is a side view similar to FIG. 2 showing the vascular devicereleased from the delivery catheter and in the first expandedconfiguration;

FIG. 4 is a perspective view of the vascular device in the firstexpanded position of FIG. 3;

FIG. 4A is a side view similar to FIG. 3 showing the vascular device ina further expanded position to penetrate the vessel wall;

FIG. 5 is a side view similar to FIG. 4A showing release of theretention member to enable expansion of the distal end of the vasculardevice;

FIG. 6 is a side view similar to FIG. 5 showing movement of the vasculardevice to the second expanded position wherein the valve leaflets aremoved radially inwardly; and

FIG. 7 is a side view showing the vascular device approximating thevalve leaflets and further showing withdrawal of the delivery catheter.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, FIGS.1-7 illustrate the vascular device of the present disclosure. Thedevice, designated generally by reference numeral 10, has a proximal(upstream) portion 12 and a distal (downstream) portion 14. The proximalportion 12 is initially expanded radially outwardly to engage theinternal wall of the vessel and then subsequently moved radiallyinwardly to pull the vessel wall radially inwardly as the distal portion14 is expanded radially outwardly. As the vessel wall is moved radiallyinwardly, the valve leaflets within the vessel are pulled closertogether to a functional condition as shown in the final position ofFIG. 7.

FIGS. 1, 6 and 7 illustrate vascular device 10 in the fully deployed orfully expanded configuration to achieve valve apposition and FIG. 2illustrates vascular device 10 in the collapsed configuration fordelivery to the vessel. Intermediate positions of the vascular device10, e.g., the first expanded configuration and second expandedconfiguration is shown in FIGS. 3 and 4A, respectively.

Vascular device 10 is preferably composed of a shape memory material,such as a nickel-titanium alloy commonly known as Nitinol, so that inits memorized configuration it assumes the shape shown in FIG. 1. Thisshape memory material characteristically exhibits rigidity in theaustenitic state and more flexibility in the martensitic state. Tofacilitate passage from the delivery catheter, the shape memory devicecan be maintained in a collapsed configuration inside a delivery sheathor catheter as described in more detail below. It can be maintained inthis position by the delivery catheter wherein upon release, it is nolonger constrained by the catheter and moves to the memorized expandedposition. Alternatively, the device can be cooled by a saline solutionwithin the delivery catheter to maintain the device below its transitiontemperature. The cold saline would maintain the temperature dependentdevice in a relatively softer condition as it is in the martensiticstate within the sheath. This facilitates the exit of device 10 from thedelivery sheath as frictional contact between the device and the innerwall of the sheath would otherwise occur if the device was maintained ina rigid, i.e., austenitic, condition. When the device 10 is releasedfrom the sheath to the target site, it is warmed by body temperature,thereby transitioning in response to this change in temperature to anaustenitic expanded condition.

In an alternate embodiment, the device is formed of stainless steel.Other materials are also contemplated.

Device 10 is preferably formed from a tubular member, preferably bylaser cutting a tube, although other methods could be utilized. Withreference to FIG. 1, device 10, as noted above, includes a proximalportion 12 and a distal portion 14. An intermediate portion 16 islocated between the proximal portion 12 and the distal portion 14.Proximal and distal, for convenience, are labeled in the direction ofblood flow, with blood flowing in a proximal to distal direction. In theexpanded condition, both the proximal and distal portions are expandedaway from a central longitudinal axis of the device.

Vascular device 10 includes six struts or legs 20, although a fewer orgreater number of struts (legs) could be provided. As shown in FIG. 1,in the fully expanded (deployed) configuration, the struts 20 angleinwardly in a proximal direction such that the distal portions of thestruts are further from a central longitudinal axis of the device 10than the proximal portions of the struts 12. Stated another way, in thisfully deployed placement position, the transverse dimension of thedistal portion of the device 10 is greater than the transverse dimensionof the proximal portion. The adjacent struts 20 are connected by aconnecting strut 22. Each connecting strut 22 is angled from a firststrut to a second adjacent strut as shown. Thus, if six struts 20 areprovided, six connecting struts 22 can also be provided. A differentnumber of struts 20 and connecting struts 22 are also contemplated.Although six longitudinal struts and six vessel engaging members areshown at the end, it should be appreciated that fewer or greater numberof struts and vessel engaging members can be utilized. Moreover, not allof the longitudinal struts need to terminate in vessel engaging membersprovided a sufficient number of struts have vessel engaging members toadequately secure the vessel.

The device 10 is preferably laser cut from a cylindrical tube, forming aseries, e.g. six, of symmetrical longitudinal strips or struts 20terminating at opposite ends in vessel engaging members 24. Thus, thestruts 20, 22 are preferably integrally (monolithically) formed fromcutouts in a tube so the term connecting strut when used herein includesextending integrally (monolithically) from a portion of the device.However, the device in alternate embodiments is not integrally formedand in this instance, the term connecting struts include separatecomponents fastened or joined (attached) together such as by welding orother methods.

The struts in the first expanded position, as shown in FIG. 3,preferably form a substantially conical shape with the proximal portionsof the struts further from the central longitudinal axis of the strutsthan the distal portions of the struts. In other words, in this firstexpanded position, the transverse dimension of the distal portion 14 ofthe device 10 is less than the transverse dimension of the proximalportion 12. In one embodiment, the transverse configuration has a longdimension and a shorter dimension, e.g., an oval. In suchconfigurations, preferably the long dimension would be substantially inline (or substantially parallel) with the valve commissure. Note a linepassing through the valve commissure where the leaflets attach to thevessel wall is substantially parallel to a transverse line passingthrough the site where the valve leaflets meet.

The struts 20 terminate at their proximal ends in vessel engagingmembers, e.g., hooks 24. These hooks 24 have vessel penetrating tips 26,extending outwardly and partially toward the distal portion 14 of thedevice 10. When the struts 20 are expanded when released from thedelivery catheter as described in more detail below, the hooks 24 engageand penetrate (pierce) the vessel wall to grasp the vessel wall. Thesharp penetrating tips 26 penetrate the vessel wall in a radialdirection and hold the vessel against axial movement with respect to thedevice 10. Barbs can be provided on the hooks 24 to restrict radialmovement of the vessel with respect to the device 10, thereby togethersecurely retaining (grasping) the vessel wall for radial inward movementdescribed below.

When the distal portion of the device 10 is subsequently expanded, theproximal portions 12 of the struts 20 pivot toward the centrallongitudinal axis of device 10 to move the vessel wall W radiallyinwardly to bring the valve leaflets L into apposition as described inmore detail below in conjunction with the method of use.

The distal portions of the struts 20 preferably terminate in bluntdistal ends 28. These ends 28 are held together during delivery by aretention member, e.g., a retaining cap 30. The retaining cap 30 can beattached to the device 10. Alternatively, the cap can be part of thedelivery device. Thus, when retaining cap 30 holds the distal ends 28 ofthe struts 20 in a converged relationship, the proximal ends of struts20 can expand radially outwardly as shown in FIGS. 3 and 4. In thismemorized first expanded configuration, the transverse cross-sectionaldimension of the proximal portion 12 is greater than the internaldiameter of the vessel wall W so that the hooks 26 can penetrate thevessel wall. It is also contemplated that alternatively, in the firstexpanded configuration, the hooks do not penetrate the vessel wall, butrequire camming of the struts by the delivery catheter. In either case,due to the retention member, the complete memorized position is notachieved at this first stage. When the retaining cap 30 is released asdescribed below, the distal ends 28 of struts 12 move radially outwardlyaway from the central longitudinal axis of device 10, causing theproximal ends of struts 20 to pivot inwardly toward the centrallongitudinal axis as shown in FIG. 6.

More specifically, the structure of the vascular device 10 is shown inits first expanded configuration in FIG. 3. Vascular device 10 iscomposed of a shape memory material, such as Nitinol, so that in itsmemorized configuration it first assumes the shape shown in FIG. 3because the distal ends 28 are retained by cap 30. Upon expansion to thefirst expanded position, the vessel engaging members 20 extend at anangle to the longitudinal axis of the vascular device 10 to enable thevessel engaging members 24 to engage and secure the vessel wall W. Thisexpansion can move penetrating hooks 26 into piercing engagement withthe vessel wall W. Alternatively, the initial expansion into the firstexpanded position can result in movement of the vessel engaging hook 20into abutment (contact) with or adjacent the vessel wall W, but not yetfully penetrating (see e.g. FIG. 3), and then the struts 20 can becammed further radially by the distal end of the delivery catheter 100to penetrate the vessel wall W as shown in. FIG. 4A. When the cap 30 isreleased, vascular device 10 assumes the shape memorized secondmemorized position of FIG. 7 (and FIG. 1) as the distal ends 28 ofstruts 20, no longer restrained, are allowed to move radially outwardlyaway from the longitudinal axis of the device 10.

There are several different methods of insertion of the vascular deviceof the present invention for treating venous valve insufficiency of thepopliteal or saphenous vein as there are various access vessels for thedelivery devices to reach these veins. For example, the deliverycatheter 100 can be placed into the popliteal vein in the patient's legand advanced to a region adjacent the leaflets “L” to deploy thevascular device upstream of the leaflets. The delivery catheter 100 isthus delivered in an antegrade fashion, with the distal tip of thedelivery catheter 100 extending upstream of leaflets “L” to deploy thedevice just upstream (defined in reference to the direction of bloodflow) of the leaflets. It alternatively can be further advanced in thisantegrade fashion downstream of the leaflets to deploy the device justdownstream of the leaflets.

In another approach, the delivery catheter 100 is inserted through theright jugular vein where it will be advanced through the superior andinferior vena cava, past the iliac vein, through the femoral vein, andinto the popliteal vein, through leaflets “L” in a retrograde fashion,i.e., opposite the direction of blood flow. The delivery catheter 100would thus extend through the leaflet region just upstream of theleaflets. Alternatively, the delivery catheter 100 can be advanced up toa region adjacent the leaflets (without passing through the leaflets) todeploy the device just downstream of the leaflets. The delivery catheter100 can in another approach be placed in the right femoral vein, whereit will be advanced in a retrograde manner to the popliteal vein.

In a contralateral approach, the delivery catheter 100 is insertedthrough the left femoral vein where it will be advanced around the iliacvein and through the right femoral vein into the popliteal vein.

The delivery catheter 100 can have tubing with a stopcock to controlsaline infusion through the catheter to maintain the vascular device 10in the cooled martensitic collapsed configuration for delivery. Aguidewire port enables insertion of a conventional guidewire (not shown)to guide the delivery catheter intravascularly to the target site. Aconventional access or introducer sheath (not shown) would be insertedthrough the skin and into the access vessel, and the delivery catheterwould be inserted into the access vessel through the introducer sheath.

FIGS. 2-7 illustrate the method steps of insertion of the vasculardevice 10 in an antegrade fashion intravascularly in the popliteal vein“P”. The catheter or delivery sheath 100 is inserted over a conventionalguidewire (not shown) so the distal tip 112 of the catheter shaftextends past, i.e. downstream, of the valve leaflets L extendingannularly from vessel wall “W” as shown in FIG. 2. As can beappreciated, since there is a gap between the valve leaflets L, thevalve cannot function properly because the leaflets cannot properlyclose to prevent backflow. Also, due to the malfunctioning of the valve,the vessel wall can become dilated (not shown) as the weight andpressure of the backflow blood pushes out the vessel wall.

Once the position of the delivery catheter 100 is confirmed byvenography, intravascular ultrasound, or other means, the catheter 100is withdrawn in the direction of the arrow of FIG. 3, exposing thevascular device 10. (Alternatively, a pusher can advance the device 10from the catheter 100). When the catheter 100 has been fully withdrawnto expose the device 10, the device 10 transitions to its austeniticphase and the first memorized expanded configuration of FIG. 4A. Theretaining cap 30 maintains the distal portion 28 of the struts 20 in theconverged position. In an alternate embodiment, the first memorizedexpanded position is that of FIG. 3, wherein the struts require afurther camming action to move the hooks 24 into the vessel wall to theposition of FIG. 4A.

In this first expanded position, vessel engaging members 24 penetratethe vessel wall (FIG. 4A), or in an alternate embodiment, move adjacentthe vessel wall and into contact with, for subsequent penetration intothe vessel wall W. In this latter embodiment, the device 10 can then bepulled proximally or the catheter 100 moved distally so that an innersurface of the struts 20, adjacent the converging region, engage theedge 112 of the catheter 100 to be cammed further radially outwardly sothat the sharp tips 26 penetrate the vessel wall to firmly grasp andsecure it as shown in FIG. 4A. The securement to the vessel wallrestricts both radial and axial movement of the vessel to enhanceretention by the device 10. In the first expanded position and in thesecond expanded position (if applicable), the transverse dimension atthe proximal portion 12 of the device 10 exceeds the transversedimension at the distal portion 14.

After retention of the vessel wall as in FIG. 4A, the cap 30 is moveddistally by distal movement of pusher rod 35, to release the distal ends8 of the struts 20 from the cap 30 as shown in FIG. 5. This causes thedistal portions 16 of struts 12 to diverge radially outwardly away fromthe central longitudinal axis, causing the proximal portions of thestruts 20 to pivot inwardly toward the central longitudinal axis,thereby moving the penetrating tips 26 and the attached vessel wallinwardly as shown in FIG. 6. That is, as the struts 20 are pivoted, dueto the engagement of the vessel engaging members 24 with the internalwall of the vessel, the vessel wall is pulled radially inwardly, therebypulling the leaflets radially inwardly to the position of FIG. 7 toclose the gap between the leaflets L. As can be appreciated, the vesselwall is no longer dilated and the valve leaflets are sufficientlyapproximated such that their tips contact to block backflow and theirfunction is therefore restored. The device 10 remains inside the vessel,maintaining the approximation of the vessel wall to maintain the properfunctioning of the leaflets.

In an alternate method of placement of the vascular device, the vasculardevice 10 is placed upstream (with respect to the direction of bloodflow) of the valve leaflets. The delivery catheter is inserted in thesame antegrade manner as described above, except it is advanced proximalof the valve leaflets L to enable upstream delivery of the device 10.Thus, the device 10 would grasp the vessel wall upstream of the valveleaflets to pull the vessel wall radially inwardly to bring the leafletsinto apposition.

As noted above, for retrograde insertion of the vascular device 10, thedelivery catheter, e.g. catheter 100, is inserted in a direction againstthe blood flow so tip 110 extends past the valve leaflets “L” in thepopliteal vein and the catheter 100 is positioned so the device 10 willbe deployed upstream of the leaflets. The device can also alternativelybe delivered in a retrograde fashion and deployed upstream of theleaflets if the tip 110 is placed upstream of the leaflets.

The vascular device 10 could also include a valve attached thereto toreplace the valve leaflets L. Thus, the dilated vessel wall is pulledradially inwardly in the manner described above, except that instead ofrelying on the leaflets L, the valve of the vascular device wouldfunction to open and close to respectively allow and block blood flow.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Forexample, instead of moving the catheter to expose the vascular device,the device can be advanced with respect to the catheter or both thecatheter and device can move relative to each other in oppositedirections. Those skilled in the art will envision many other possiblevariations that are within the scope and spirit of the disclosure asdefined by the claims appended hereto.

1-11. (canceled)
 12. A method for treating venous valve insufficiencycomprising the steps of: inserting a delivery device and a vasculardevice having a plurality of legs into a target vessel adjacent valveleaflets of the vessel; deploying the vascular device from the deliverydevice to move a proximal portion of the legs radially outwardly toengage a wall of the vessel; and releasing a distal portion of the legsto move the proximal portion of the legs radially inwardly to move thevessel wall radially inwardly and bring the valve leaflets closertogether.
 13. The method of claim 12, wherein the step of releasing thedistal portion of the legs includes moving a retention member of thevascular device axially.
 14. The method of claim 12, wherein the step ofreleasing the distal portion of the legs enables the vascular device toreturn to a shape memorized position.
 15. The method of claim 12,further comprising the step of pulling the retention member proximallyto move the legs proximally into contact with the delivery device, thedelivery device camming the legs further outwardly.
 16. The method ofclaim 12, wherein the proximal portion of the legs have vesselpenetrating members, and wherein in an expanded deployed position of thevascular device, the vessel engaging members are spaced from a centerlongitudinal axis of the vascular device a radial distance less than aradial distance distal portions of the legs are spaced from the centerlongitudinal axis.
 17. The method of claim 12, wherein the deliverydevice is inserted to a position upstream of the valve leaflets todeliver the vascular device upstream of the valve leaflets.
 18. Themethod of claim 12, wherein the delivery device is inserted to aposition downstream of the valve leaflets to deliver the vascular devicedownstream of the valve leaflets.
 19. The method of claim 12, whereinthe vascular device is inserted through the saphenous vein or thepopliteal vein to a position downstream of the valve leaflets.
 20. Themethod of claim 12, wherein the vascular device is inserted through thesaphenous vein or the popliteal vein to a position upstream of the valveleaflets.
 21. The method of claim 12, wherein the step of releasing thedistal portion of the legs releases the legs from a converged position.22. The method of claim 21, wherein release of the legs causes distaltips of the legs to diverge radially outwardly.
 23. The method of claim12, wherein the device is substantially conical in configuration. 24.The method of claim 12, wherein the device is substantially oval intransverse cross-section to form a shorter dimension and a longerdimension and the longer dimension is substantially parallel with avalve commissure.
 25. The method of claim 12, wherein the device isformed from a tube and the struts are formed from cutouts in the tube.26. The method of claim 12, wherein the device includes a retentionmember retaining the distal portion of the legs and the step ofreleasing a distal portion of the legs includes the step of releasingthe retention member.
 27. The method of claim 12, wherein the device hasfree ends at the proximal portion and distal portion.
 28. The method ofclaim 12, wherein release of the legs causes distal tips of the legs todiverge radially outwardly.
 29. The method of claim 22, wherein thedevice has free ends at the proximal portion and distal portion.